CLINICAL TRIALS PROFILE FOR VARESPLADIB
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Clinical Trials for Varespladib
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT00434473 ↗ | IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome | Completed | Anthera Pharmaceuticals | Phase 2 | The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL. |
NCT00533039 ↗ | sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial | Completed | Anthera Pharmaceuticals | Phase 2 | As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function. |
NCT00533039 ↗ | sPLA2 Inhibition to Decrease Enzyme Release After PCI Trial | Completed | University Health Network, Toronto | Phase 2 | As evidence accumulates that atherogenesis or Coronary Artery Disease (CAD) may not be simply a disorder of lipid metabolism, but an inflammatory disease, the focus of treatment has shifted. A-002 or Varespladib is an anti-inflammatory drug for treatment of chronic and acute diseases. It acts by inhibiting secretory phospholipase A2 (sPLA2 ) - one of a family of enzymes leading to inflammation - which may be important in: 1) the development of atherosclerosis and 2) the increase in occurence of cardiovascular events after angioplasty. Previous studies have demonstrated that sPLA2: 1) facilitates the pro-atherogenic effects of low-density (LDL or bad cholesterol) and 2) increased levels post-angioplasty correlate with an increased risk of events at followup contact. Therefore this study proposes to investigate the ability of A-002 to prevent or reduce myocardial damage after angioplasty by inhibiting the cascade of inflammatory mediators. Substudy - Subjects who agree will also have a vascular ultrasound 24h post-PCI to assess endothelial function. |
NCT00743925 ↗ | FRANCIS-ACS Trial: A Study of the Safety and Efficacy of A 002 in Subjects With Acute Coronary Syndromes | Completed | Anthera Pharmaceuticals | Phase 2 | The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome (ACS) |
NCT01130246 ↗ | VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome | Terminated | Anthera Pharmaceuticals | Phase 3 | The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS). |
NCT01359579 ↗ | A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function | Terminated | Anthera Pharmaceuticals | Phase 1 | The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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